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RoHS for Disposable Medical Device Assemblies

M

meddev_thi

#1
Hi, Our medical device system contains a controller and a kit. The controller contains electronic parts, and it will most likely go into the landfill (environment) after end of life and therefore must be RoHS compliant. The kit contains 5 individual disposable assemblies. One of the assemblies contains one electronic part (pressure sensor). All the disposable assemblies will be disposed of via the biohazard waste stream. With that said, would the assembly that contains the electronic part also need to be RoHS compliant? We are going to obtain RoHS compliance data for the pressure sensor, but would the whole assembly (i.e. tube, barb lock, glue) need to be RoHS compliant ?

I am under the impression that RoHS focuses on equipment going into the landfill waste stream, which is why I am thinking that the disposable (even though there is an electronic part in there) will not be part of RoHS because it is not going into the landfill; it is being treated as biohazard and be disposed of in that manner.

However, it seems like implantable will have to comply to RoHS in a couple of years, and that is also disposed of via the biohazard waste stream. My disposables are not implantable, but when implantable fall under RoHS, then my argument will not work.

Please help.

thanks!
 
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